Study of Pentasa® for Reducing Residual Systemic Immune Activation in Treated HIV Infection
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AIDS Healthcare Foundation
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Inflammation markers
Study Overview
Brief Summary
An open label study will be performed on 80 people with HIV infection who are maintained on effective treatment with antiretroviral drugs.
Detailed Description
The goal of this study is to test whether a bowel anti-inflammatory drug that is known to be safe and effective for inflammatory bowel disease would offer benefit in reducing the residual immune activation associated with treated HIV-1 infection. Specifically, the two immediate goals are to examine the safety of Pentasa® in reducing markers of immune activation believed to be important reflectors of risk for cardiovascular disease and ongoing immune damage in people with chronic treated HIV-1 infection.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age at least 18
- •On ART for at least 1 year during which: viremia <50 RNA copies/ml for at least 3 measurements (allowing for 1 nonconsecutive blip of <100), and CD4 T cell count consistently >500 during that time
- •CD4 T cell nadir >350
- •Last CD4 and T cell test in past 6 months
Exclusion Criteria
- •Plans to modify antiretroviral therapy in the next 12 weeks for any reason
- •History of inflammatory bowel disease or irritable bowel disease
- •Chronic active hepatitis B or C
- •History of autoimmune disease
- •Hypersensitivity to any component of Pentasa
- •Clostridium difficile infection
- •Receiving rectally delivered medications
- •Receiving anti-inflammatory medications (such as nonsteroidal anti- inflammatory drugs, steroids, or TNF inhibitors)
- •Receiving immunosuppressive steroids
- •Receiving any medications associated with bleeding risk
- •Hemoglobin < 10.0 g/dL
- •Platelet count less than 100,000/mm3
- •White blood cell count < 2,000 cells/mm3 or > 15,000 cells/mm3
- •Symptoms of sexually transmitted infection
- •Antibiotics used in the last 90 days
- •Renal insufficiency with creatinine clearance less than 50 ml/min
- •Elevated transaminases greater than 2.5 times the upper limit of normal
- •Evidence of decompensated cirrhosis, heart failure
- •Pregnant or breastfeeding women
Arms & Interventions
Pentasa
40 participants will be randomized to take 1 gram of Pentasa, twice daily for 8 weeks
Intervention: Pentasa vs Align (Drug)
Align
40 participants will be randomized to take Align tablets, once daily for 8 weeks
Intervention: Pentasa vs Align (Drug)
Outcomes
Primary Outcomes
Inflammation markers
Time Frame: 14 weeks
C-reactive protein
Secondary Outcomes
- Plasma markers of microbial translocation(14 weeks)
- Flow cytometry for cellular immune activation(14 weeks)